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“It’s fair to say that Secretary Clinton’s defeat will take the focus off pharmaceutical
prices in the short term,” John W. Treece, with Sidley & Austin LLP in Chicago, said.
Treece, a practice area team leader in Sidley’s antitrust and competition practice,
represents several pharmaceutical company clients.

New Leader at FDA?

The FDA leadership is also likely in for a shake-up, too, life sciences lawyers said.

FDA Commissioner Robert Califf may be on his way out, said David L. Rosen, a life
sciences lawyer with Foley & Lardner LLP in Washington. Trump is probably going to want to start with a clean slate across the board, said
Rosen, who previously worked at the FDA.

Significant staff turnover is also likely at the FDA, particularly in key leadership
positions, according to Gregory H. Levine, co-chair of Ropes & Gray LLP’s Life Sciences
practice group in Washington.

Industry’s not likely to take a favorable view of changes at the FDA because businesses
like certainty and they are used to dealing with the current players, David A. Manspeizer
said. Manspeizer, an intellectual property lawyer at Morrison & Foerster LLP’s New
York office, was previously vice president of intellectual property and associate
general counsel at pharmaceutical and biotechnology company Wyeth.

Ty E. Howard, of Bradley Arant Boult & Cummings LLP in Nashville, agreed. “So much
of the campaign and the Trump candidacy was unconventional that it is hard for businesses
to predict what’s next,” he said. Howard is chair of Bradley’s Government Enforcement
and Investigations group and represents clients in health care as well as other industries.

Trade Renegotiation Worries Industry

Trump’s tough stance on trade issues with China and other countries could also have
negative repercussions for the life sciences industry, according to Levine, of Ropes
& Gray.

Potential changes in trade policy cut across many industries, Howard said. Those changes
have broader implications for the economy as a whole, including the pharmaceutical,
biotechnology and device sectors, he said.

“Industry will be concerned about Trump reopening trade agreements and the possibility
of renegotiating those agreements,” Manspeizer said.

Could Drug Reimportation Resurface?

There’s also the possibility that the issue of whether cheaper drugs can be legally
imported into the U.S. could resurface, Manspeizer said.

Trump has made “vague statements” on importation and the reimportation of drugs from
Canada, he said. Trump has also made statements about opening up Medicare Part D,
which covers prescription drugs, to price negotiation, Manspeizer said.

The lack of “meat on the bones” on any of Trump’s statements makes it difficult to
predict what, if anything, could move forward in these areas, he said.

Drug Approvals Could Be Quicker

But the new political leadership contains plenty of potential upsides for the life
sciences industry, too.

Expediting drug approvals and reducing regulatory burdens are among those upsides,
Levine said.

“There is some speculation that the FDA approval process may become faster and may
allow more and quicker approvals,” Holdreith said.

Information Sharing May Increase

Drug and device makers may also get a freer hand to share information with health
care providers about unapproved uses of their products.

Currently, FDA regulations prohibit manufacturers from sharing information about uses
of their products that the agency hasn’t approved. The drug industry has been litigating
over this issue seeking to lessen these restrictions.

A more conservative Supreme Court is likely to continue the trend of extending First
Amendment protections to commercial speech including manufacturers’ ability to disseminate
information about unapproved or off-label uses of products, Levine said.

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